A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer

Tracking Information
First Submitted Date ICMJE	July 18, 2006
First Posted Date ICMJE	July 20, 2006
Last Update Posted Date	January 7, 2011
Study Start Date ICMJE	February 2007
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 10, 2007)	Progression-free Survival [ Time Frame: Subjects may remain on study until disease progression ]
Original Primary Outcome Measures ICMJE; (submitted: July 18, 2006)	Maximum Tolerated Dose; Progression-free Survival
Change History	Complete list of historical versions of study NCT00354562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 10, 2007)	Overall Survival [ Time Frame: Subject may remain on study until disease progression ]; Response Rate [ Time Frame: Subject may remain on study until disease progression ]; Time-to-Progression (TTP) [ Time Frame: Subject may remain on study until disease progression ]
Original Secondary Outcome Measures ICMJE; (submitted: July 18, 2006)	Overall Survival; Response Rate; Duration of response; Time-to-Progression (TTP); Quality of Life (QoL); Treatment related toxicities
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
Official Title ICMJE	A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Brief Summary	To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Lung Cancer; Non-Small Cell Lung Cancer
Intervention ICMJE	Drug: ABT-751 200mg ABT-751 daily for 14 days every 21 days; Drug: Placebo Placebo daily for 14 days every 21 days; Drug: Docetaxel Standard Docetaxel every 21 days Other Name: Taxotere
Study Arms	Active Comparator: A Docetaxel + ABT-751 Interventions: Drug: ABT-751 Drug: Docetaxel; Placebo Comparator: B Docetaxel + placebo Interventions: Drug: Placebo Drug: Docetaxel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: January 5, 2011)	75
Original Enrollment ICMJE; (submitted: July 18, 2006)	20
Study Completion Date	Not Provided
Actual Primary Completion Date	February 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Pathologically documented NSCLC; Locally advanced (Stage III) or metastatic (Stage IV) NSCLC; Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy); Only one prior anti-tumor treatment regimen in the curative setting; Progressive disease following the previous anti-tumor treatment regimen; Measurable disease by RECIST criteria; Brain metastasis must be stable and well-controlled ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent; Only one prior anti-tumor treatment regimen in the curative setting; Progressive disease following the previous anti-tumor treatment regimen; Measurable disease by RECIST criteria; Brain metastasis must be stable and well-controlled; ECOG performance score 0-2; All anti-tumor therapy discontinued at least 3 weeks prior to study entry; All adverse events from prior treatment are resolved or stable; Adequate hematologic, renal, and hepatic function; Females must not be pregnant; Willing to take adequate measures to prevent pregnancy; Life expectancy of at least 3 months; Able to complete the Quality of Life questionnaire; Voluntarily signed informed consent Exclusion Criteria: Greater that Grade 1 neurological findings; Allergy to sulfa medications; Previous treatment with ABT-751 or docetaxel; Receipt of more than one investigational agent for NSCLC; Significant weight loss (>10%) within 6 weeks of study entry; Glucose-6-phosphate dehydrogenase deficiency or porphyria; Significant systemic disease that would adversely affect participation; Class 3-4 New York Heart Association classification status; Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, Ireland, United Kingdom, United States
Removed Location Countries	Puerto Rico
Administrative Information
NCT Number ICMJE	NCT00354562
Other Study ID Numbers ICMJE	M05-782; 2006-002838-38 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Helen Eliopoulos, MD, Global Project Head, Abbott
Study Sponsor ICMJE	Abbott
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Helen Eliopoulos, MD Abbott
PRS Account	Abbott
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP